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Anti-metabolites

Nivolumab + Methotrexate/5-Azacytidine for Recurrent Brain Tumors

Phase 1

Recruiting

Led By David I. Sandberg, MD

Research Sponsored by David Ilan Sandberg

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 1 - 80 years at time of recurrence or progression

Minimum body weight of 10 kilograms

Must not have

Patient that has had allogenic stem cell transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of treatment to end of treatment (about 12 weeks)

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test the safety and effectiveness of using nivolumab with 5-azacytidine for recurrent ependymoma, and nivolumab with methotrexate

Who is the study for?

This trial is for people with recurrent brain tumors like medulloblastoma and ependymoma. Participants should have a tumor that can be measured, no prior immunotherapy, and adequate organ function. They must not have an active infection or another cancer, be pregnant, or have had recent surgery.

What is being tested?

The study tests the safety and tumor-fighting ability of nivolumab (an immune system booster) combined with either methotrexate or 5-azacytidine (chemotherapy drugs), delivered directly into the fourth ventricle of the brain to treat recurring brain tumors.

What are the potential side effects?

Possible side effects include inflammation in various organs due to immune response, infusion-related reactions from nivolumab; liver toxicity and mouth sores from methotrexate; nausea, low blood cell counts leading to increased infection risk from 5-azacytidine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 1 and 80 years old and my cancer has come back or gotten worse.

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I weigh at least 10 kilograms.

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I have or agree to get a catheter placed for my brain tumor treatment.

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I am mostly active and can do most of my daily activities.

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I haven't taken any cancer treatment drugs or experimental drugs in the last 7 days.

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I have recovered from the side effects of my previous cancer treatments.

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I had specific cell or viral therapy over 3 months ago, or a stem cell transplant with no ongoing complications.

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My blood counts, liver, and kidney functions are within safe ranges for treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a stem cell transplant from a donor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of treatment to end of treatment (about 12 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of treatment to end of treatment (about 12 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment to end of treatment (about 12 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety as assessed by the number of participants with a new neurological toxicity that is graded as Grade 3 or higher and that is probably or definitely related to infusions [that is, classified as dose-limiting toxicity (DLT)]

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Nivolumab plus MethotrexateExperimental Treatment2 Interventions

Enrolled patients with medulloblastoma and other CNS malignancies will receive: 1. Intraventricular Methotrexate infusions 2 mg daily for 4 consecutive days per week every other week on weeks 1, 3, 5, 7, 9, and 11. 2. Intraventricular Nivolumab infusions. Nivolumab will be administered once every other week on weeks 2, 4, 6, 8, 10, and 12. Dosing will be based upon patient body weight.

Group II: Nivolumab plus 5-AzacytidineExperimental Treatment2 Interventions

Enrolled patients with ependymoma will receive: 1. Intraventricular 5-Azacytidine infusions 10 mg once weekly for twelve consecutive weeks. 2. Intraventricular Nivolumab infusions once every other week on weeks 1, 3, 5, 7, 9, and 11. Dosing will be based upon patient body weight.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

5-Azacytidine

2015

Completed Phase 2

~270